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NCT ID: NCT05908292 Recruiting - Perineal Tear Clinical Trials

Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT

EPIS
Start date: September 21, 2023
Phase: N/A
Study type: Interventional

The goal of this Pilot Randomized Control Trial (RCT) is to determine if a larger RCT evaluating the effect of self-scar tissue massage of episiotomy and/or vagina/perineal tear scar tissue on pelvic health outcomes is feasible. The main questions it aims to answer are: Can the investigators recruit 130 participants and aim for 80% retention of participants in this study? Are the response rates to questionnaires and completeness of questionnaires acceptable? Do the participants find the self-scar tissue massage intervention easy and acceptable to perform and do they adhere to the protocol? Type of Study: Clinical Trial Participant Population/Health Conditions: The participant population will be 18 years of age or older, primiparous, within 1 year postpartum after vaginal delivery with healed episiotomy and/or vaginal perineal tear(s) as confirmed to them by their maternity care provider or family doctor at their 6 week postpartum check or other appointment. The participants will also need to have sufficient proficiency in English to understand intervention instructional video and complete written questionnaires. Investigators will compare the scores on two reliable and validated pelvic health questionnaires in those in the intervention and control groups. The intervention group will be provided an instructional video on self-scar tissue massage and asked to perform self-scar massage and record their intervention and experience over a 6-week period. The control group will receive routine postnatal care (no self-scar massage training or performance). Patient medical records will be used to collect demographic data and labour and delivery characteristics. Two reliable and validated pelvic health questionnaires will be used for outcome measures. Baseline outcomes will be performed at the start of the study and then repeated 6 weeks later and again 18 weeks later.

NCT ID: NCT05907954 Recruiting - Uveal Melanoma Clinical Trials

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

Start date: July 3, 2023
Phase: Phase 2
Study type: Interventional

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

NCT ID: NCT05907304 Recruiting - Clinical trials for Advanced or Metastatic Solid Tumors

A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations

SEACRAFT-1
Start date: August 17, 2023
Phase: Phase 1
Study type: Interventional

To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors - To evaluate the safety and tolerability of naporafenib administered with trametinib in patients with RAS Q61X solid tumors - To characterize the pharmacokinetic (PK) profile of naporafenib and trametinib when administered to patients with RAS Q61X solid tumors

NCT ID: NCT05907096 Recruiting - Clinical trials for Delayed Graft Function

ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function

VARVARA
Start date: February 17, 2024
Phase: Phase 2
Study type: Interventional

This is a phase 2 study to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function

NCT ID: NCT05905367 Recruiting - Opioid Use Disorder Clinical Trials

Symptom-inhibited Fentanyl Induction

SIFI
Start date: January 29, 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to test a treatment strategy for individuals with opioid use disorder (OUD) who use fentanyl. Participants will receive medically-administered doses of intravenous (IV) fentanyl at intervals until they are comfortable and do not have withdrawal symptoms. They then will be given opioid agonist therapy (OAT) once daily by mouth, which is the current standard treatment for OUD. In this trial, each participant's starting dose of OAT will be tailored to meet their opioid needs, based on the amount of IV fentanyl they received. The main questions this trial aims to answer are: - Is the IV fentanyl protocol feasible and safe for use in a community clinic setting? - Will the protocol result in higher-than-standard starting doses of OAT? Are these doses safe, and will they enable participants to stay on OAT for a longer time?

NCT ID: NCT05905003 Recruiting - Psychosis Clinical Trials

AMP SCZ® Observational Study: PREDICT-DPACC

AMP SCZ
Start date: June 2, 2022
Phase:
Study type: Observational

The Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) is a large international collaboration to develop algorithms using a set of clinical and cognitive assessments, multi-modal biomarkers, and clinical endpoints that can be used to predict the trajectories and outcomes of individuals at clinical high risk (CHR) for psychosis and to advance the testing of pharmacological interventions for CHR individuals in need. The goal is to accurately predict which individuals are likely to remit, experience an acute psychotic episode, or have intermediate outcomes that feature persistent attenuated psychotic and/or mood symptoms along with functional impairment. The prediction algorithms will have the potential to serve as early indicators of treatment efficacy in CHR persons. The AMP SCZ research program is made up of the Psychosis Risk Evaluation, Data Integration, and Computational Technologies - Data Processing, Analysis and Coordination Center (PREDICT-DPACC) and two clinical research networks, the Psychosis-Risk Outcomes Network (ProNET) and the Trajectories and Predictors in the Clinical High Risk for Psychosis Population: Prediction Scientific Global Consortium (PRESCIENT) networks. The two clinical research networks will recruit a large cohort of CHR young people aged 12-30 years (n=1,977) and healthy control (HC) participants (n=640) across 42 participating investigative sites from 13 countries. CHR participants will complete screening, baseline assessments and a battery of follow-up assessments across 18 - 24 months. HC participants will complete screening and baseline assessments and a subset (5 per site) will complete month 2, 12 and 24 visits.

NCT ID: NCT05904886 Recruiting - Clinical trials for Carcinoma, Hepatocellular

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (IMbrave152)

SKYSCRAPER-14
Start date: September 14, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic hepatocellular carcinoma (HCC).

NCT ID: NCT05904470 Recruiting - Hepatitis C Clinical Trials

A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV

Start date: May 30, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.

NCT ID: NCT05902364 Recruiting - Dry Eye Clinical Trials

Systane® Ultra Preservative Free Lubricant Eye Drops

Start date: October 28, 2023
Phase: N/A
Study type: Interventional

The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Ultra Preservative-Free (PF) in subjects experiencing dry eye symptoms (Group 1) and contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2). Statistical analyses will be presented by group. This study will be conducted in Canada, Australia, and New Zealand.

NCT ID: NCT05902325 Recruiting - Clinical trials for Chronic Rhinosinusitis With Nasal Polyps

Identifying Predictors Of Response To Mepolizumab In CRSwNP

ISS-RESMEPO
Start date: October 3, 2023
Phase: Phase 4
Study type: Interventional

The investigators propose a real-world study to assess the mechanism of action of long-lasting response to mepolizumab in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and identify clinically useful predictors of response. Mepolizumab is a monoclonal antibody targeting IL-5 and is approved for use in asthma and CRSwNP. In clinical studies, 12 months of treatment with mepolizumab improved signs and symptoms of CRSwNP and reduced the need for surgery. While several biologic medications targeting facets of the Type 2 mechanism are currently indicated for chronic rhinosinusitis with nasal polyps mepolizumab alone appears capable of modifying the disease's biological behaviour and producing long-standing improvements after the cessation of treatment. In the mepolizumab for CRSwNP regulatory trial (SYNAPSE), a subset of patients experienced dramatic and long-lasting, which is over 48 months after cessation of administration of the investigational medicinal product (IMP) in our experience. This has been partially captured in a follow-on study to the registration trail, which showed that a subset of patients followed for 24 weeks after cessation of biologic therapy (with continued use of mometasone furoate) demonstrated persistent improvements over baseline. However, the mechanism of the long-lasting effect in a subset of patients is not well understood, and it is impossible currently to identify patients who will derive this maximal benefit. The mechanism for the prolonged improvements in CRSwNP seen in certain patients with mepolizumab remains to be established but suggests that effects beyond eosinophil trafficking are implicated. The investigators believe that mepolizumab has IL-5-mediated pleiotropic effects which contribute to disease modification with effects extending beyond eosinophil activation and trafficking. This may include the following primary or secondary effects: i) Improving epithelial barrier function ii) Altering mast cell dynamics iii) Reversing epigenetic modifications iv) Altering the immune response to better clear pathogenic bacteria or viruses.